Application for amendment
The application for changes – or amendment – of an already approved ethical application must be made via the Ethics Review Authority’s application portal ETHIX. The application has to be completed in Swedish with the Swedish documents.
Information and translation in English of the Swedish documents can be found on the webpage of the Ethics Review Authority . The English documents are only for guidance.
The application must be signed by the principal investigator and the dean of school.
A significant change is typically altering the security of the participants, or the risk-benefit balance. Examples of significant changes that may require an amendment application:
- Change of research principal or principal investigator.
- Many more research samples/subjects/participants should be included.
- New units or study places should be involved.
- New methods or new analyses should be performed on material already collected (under the same main issue).
If a change to an original project is extensive, such as a new study approach or study hypothesis, new groups of research samples/subjects/participants with characteristics other than the original ones, a completely new application may need to be done.